Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy

Launched by GANG XU · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of taking probiotics along with a medication called enteric-coated budesonide in patients with a kidney condition known as primary IgA nephropathy. The main goal is to see if combining these probiotics with budesonide can help reduce protein levels in urine, which can be a sign of kidney problems. Participants will either receive the probiotics or a placebo (a harmless sugar pill) for about 9.5 months while continuing their usual kidney treatment. They will also keep track of their symptoms and visit the clinic 13 times during the study.

To participate, individuals need to be adults aged 18 to 70 who have been diagnosed with primary IgA nephropathy through a kidney biopsy and have specific levels of protein in their urine. Certain health issues, like severe gastrointestinal diseases or serious infections, would prevent someone from joining the trial. It’s important for eligible participants to understand the trial's requirements and be willing to follow the procedures. This study is currently not recruiting participants, but it aims to learn more about how gut health may relate to kidney health in these patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult age: 18\~70 years old;
• • 2. Renal biopsy-confirmed primary IgA nephropathy;
• • 3. 24-h urine protein excretion ≥ 0.75g, or urinary protein creatinine ratio (UPCR) ≥ 0.5g/g;
• • 4. eGFR ≥ 30mL/min/1.73m\^2 estimated with the Chronic Kidney Disease Epidemiology Collaboration 2009 formula (CKD-EPI2009);
• • 5. Fertile men and female of childbearing age need to use highly effective contraceptive measures from the time they sign informed consent to the end of the safety follow-up period;
• • 6. Sign the informed consent, understand and agree to comply with the requirements of the study and the trial procedures.
• Exclusion Criteria:
• • 1. Secondary form of IgA nephropathy or any non-IgA nephropathy Glomerulonephritis;
• • 2. Specific types of IgA nephropathy (including minor lesions with mesangial IgA deposition, rapidly progressive and crescentic IgA nephropathy, etc.) and other glomerular diseases (such as diabetic nephropathy, etc.);
• • 3. 24-h urine protein excretion \>5g;
• • 4. Renal biopsy showed crescent ≥25%;
• • 5. A history of severe gastrointestinal disease (such as active peptic ulcer disease, active gastrointestinal bleeding, gastrointestinal perforation, inflammatory bowel disease, and chronic diarrhea) or a history of gastrointestinal surgery;
• • 6. Complicated with malignant tumors (diagnosed within the past 5 years), cerebral infarction, cerebral hemorrhage, myocardial infarction, arrhythmia, heart failure and other serious primary diseases;
• • 7. The presence of severe chronic or active infections (including but not limited to tuberculosis) that require systemic antimicrobial, antifungal, antiviral, or antiparasitic treatment;
• • 8. A history of cirrhosis;
• • 9. Severe osteoporosis requiring treatment;
• • 10. Received organ transplants;
• • 11. Glaucoma or cataracts who currently require clinical treatment;
• • 12. Diagnosed with uncontrolled mental illness;
• • 13. Participants with poorly controlled type 1 or type 2 diabetes (glycated haemoglobin \[HbA1c\] \>8%;
• • 14. Laboratory tests for abnormal liver function (ALT and/or AST\> 2 times the upper normal limit, ALP\> 2.5 times the upper normal limit);
• • 15. The blood total cholesterol was seriously abnormal (\>12.92mmol/L);
• • 16. Human immunodeficiency virus antibody positive, treponema pallidum antibody positive, hepatitis B surface antigen positive, hepatitis C antibody positive;
• • 17. Currently using a potent inhibitor of cytochrome P4503A4 (CYP3A4) and cannot be discontinued during the study;
• • 18. Known allergy or intolerance to ACEI, ARB, budesonide or any component of the investigational drug formulation;
• • 19. Use of antibiotics, glucocorticoids or other immunosuppressants, foods and medicines containing probiotics/prebiotics within the past 3 months;
• • 20. Pregnant or lactating participants;
• • 21. Also accepting participants from other clinical trials;
• • 22. Participants who have been determined by the researchers to be unable to complete on time.